SLS II/GlideLight catheters
FDA premarket approval P960042/S062 · decided 2018-06-28
Approval details
- PMA number
- P960042
- Supplement
- S062
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SLS II/GlideLight catheters
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2018-06-08
- Decision date
- 2018-06-28
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for an additional visual inspection on the marker band on the distal tip of the SLS GlideLight laser lead extraction catheters.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.